{"id":4278,"date":"2025-03-10T08:45:00","date_gmt":"2025-03-10T08:45:00","guid":{"rendered":"http:\/\/biogroupvietnam-worldpress.local\/2025\/08\/18\/regulations-on-the-use-of-fbs-hpl\/"},"modified":"2025-09-29T14:00:15","modified_gmt":"2025-09-29T07:00:15","slug":"nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/","title":{"rendered":"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL theo ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf"},"content":{"rendered":"<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">Khi l\u0129nh v\u1ef1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 gen ti\u1ebfn tri\u1ec3n, c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u0111ang th\u1eaft ch\u1eb7t c\u00e1c h\u01b0\u1edbng d\u1eabn xung quanh vi\u1ec7c s\u1eed d\u1ee5ng Huy\u1ebft thanh b\u00e0o thai b\u00f2 (FBS) v\u00e0 D\u1ecbch ly gi\u1ea3i ti\u1ec3u c\u1ea7u ng\u01b0\u1eddi (HPL). C\u00e1c c\u01a1 quan nh\u01b0 FDA v\u00e0 EMA hi\u1ec7n \u0111ang nh\u1ea5n m\u1ea1nh vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c v\u1eadt li\u1ec7u kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt\/con ng\u01b0\u1eddi. H\u1ecd t\u1eadp trung v\u00e0o vi\u1ec7c c\u1ea3i thi\u1ec7n t\u00ednh an to\u00e0n, t\u00ednh nh\u1ea5t qu\u00e1n v\u00e0 kh\u1ea3 n\u0103ng t\u00e1i t\u1ea1o c\u1ee7a c\u00e1c s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.<\/span><\/p>\n<p>&nbsp;<\/p>\n<figure class=\"image\"><img fetchpriority=\"high\" decoding=\"async\" style=\"aspect-ratio:2240\/1260\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/CellCor\u2122-MSC-CD-AOF-chuyen-doi-nuoi-cay-te-bao-1.png\" alt=\"CellCor\u2122 MSC CD AOF h\u1ed7 tr\u1ee3 chuy\u1ec3n \u0111\u1ed5i nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o\" width=\"2240\" height=\"1260\"><figcaption><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\"><i>CellCor\u2122 MSC CD AOF h\u1ed7 tr\u1ee3 chuy\u1ec3n \u0111\u1ed5i nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o<\/i><\/span><\/figcaption><\/figure>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#Cac_huong_dan_quy_dinh_su_dung_FBS_va_HPL\" >C\u00e1c h\u01b0\u1edbng d\u1eabn quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#FDA_%E2%80%93_Huong_dan_CMC_cho_lieu_phap_gen_nguoi_2020\" >FDA \u2013 H\u01b0\u1edbng d\u1eabn CMC cho li\u1ec7u ph\u00e1p gen ng\u01b0\u1eddi (2020)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#ICH_Q5AR2_%E2%80%93_Danh_gia_an_toan_ve_vi-rut_2024\" >ICH Q5A(R2) \u2013 \u0110\u00e1nh gi\u00e1 an to\u00e0n v\u1ec1 vi-r\u00fat (2024)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#EMA_%E2%80%93_Yeu_cau_ve_chat_luong_phi_lam_sanglam_sang_doi_voi_lieu_phap_te_bao_Ban_thao_2019\" >EMA \u2013 Y\u00eau c\u1ea7u v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng phi l\u00e2m s\u00e0ng\/l\u00e2m s\u00e0ng \u0111\u1ed1i v\u1edbi li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o (B\u1ea3n th\u1ea3o, 2019)<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#EMA_%E2%80%93_Huong_dan_ve_cac_san_pham_thuoc_dua_tren_te_bao_nguoi_2008\" >EMA \u2013 H\u01b0\u1edbng d\u1eabn v\u1ec1 c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c d\u1ef1a tr\u00ean t\u1ebf b\u00e0o ng\u01b0\u1eddi (2008)<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#Su_chuyen_doi_sang_moi_truong_nuoi_cay_CD_va_AOF\" >S\u1ef1 chuy\u1ec3n \u0111\u1ed5i sang m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y CD v\u00e0 AOF<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#Ban_da_san_sang_cho_su_chuyen_doi_trong_nuoi_cay_te_bao\" >B\u1ea1n \u0111\u00e3 s\u1eb5n s\u00e0ng cho s\u1ef1 chuy\u1ec3n \u0111\u1ed5i trong nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/#Phu_luc\" >Ph\u1ee5 l\u1ee5c<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Cac_huong_dan_quy_dinh_su_dung_FBS_va_HPL\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>C\u00e1c h\u01b0\u1edbng d\u1eabn quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"FDA_%E2%80%93_Huong_dan_CMC_cho_lieu_phap_gen_nguoi_2020\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:16pt\"><strong>FDA \u2013 H\u01b0\u1edbng d\u1eabn CMC cho li\u1ec7u ph\u00e1p gen ng\u01b0\u1eddi (2020)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">C\u00e1c v\u1eadt li\u1ec7u c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt c\u00f3 th\u1ec3 \u0111\u01b0a v\u00e0o c\u00e1c t\u00e1c nh\u00e2n ng\u1eabu nhi\u00ean. \u0110i\u1ec1u n\u00e0y d\u1eabn \u0111\u1ebfn s\u1ef1 thay \u0111\u1ed5i theo t\u1eebng l\u00f4, \u1ea3nh h\u01b0\u1edfng \u0111\u1ebfn t\u00ednh nh\u1ea5t qu\u00e1n c\u1ee7a s\u1ea3n ph\u1ea9m. N\u00ean c\u00e2n nh\u1eafc s\u1eed d\u1ee5ng c\u00e1c thu\u1ed1c th\u1eed kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt (v\u00ed d\u1ee5: m\u00f4i tr\u01b0\u1eddng kh\u00f4ng c\u00f3 huy\u1ebft thanh hay protease t\u00e1i t\u1ed5 h\u1ee3p). N\u1ebfu s\u1eed d\u1ee5ng huy\u1ebft thanh th\u00ec ch\u00fang c\u1ea7n ph\u1ea3i \u0111\u01b0\u1ee3c chi\u1ebfu x\u1ea1 \u03b3 \u0111\u1ec3 gi\u1ea3m nguy c\u01a1 nhi\u1ec5m b\u1ea9n.&nbsp;<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"ICH_Q5AR2_%E2%80%93_Danh_gia_an_toan_ve_vi-rut_2024\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:16pt\"><strong>ICH Q5A(R2) \u2013 \u0110\u00e1nh gi\u00e1 an to\u00e0n v\u1ec1 vi-r\u00fat (2024)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">Nh\u1ea5n m\u1ea1nh v\u1ea5n \u0111\u1ec1 gi\u1ea3m thi\u1ec3u vi\u1ec7c s\u1eed d\u1ee5ng c\u00e1c v\u1eadt li\u1ec7u c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb con ng\u01b0\u1eddi v\u00e0 \u0111\u1ed9ng v\u1eadt \u0111\u1ec3 gi\u1ea3m nguy c\u01a1 nhi\u1ec5m vi-r\u00fat. Khuy\u1ebfn ngh\u1ecb tr\u00e1nh s\u1eed d\u1ee5ng huy\u1ebft thanh ng\u01b0\u1eddi, huy\u1ebft thanh b\u00f2 ho\u1eb7c trypsin l\u1ee3n trong c\u00e1c quy tr\u00ecnh s\u1ea3n xu\u1ea5t.<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"EMA_%E2%80%93_Yeu_cau_ve_chat_luong_phi_lam_sanglam_sang_doi_voi_lieu_phap_te_bao_Ban_thao_2019\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:16pt\"><strong>EMA \u2013 Y\u00eau c\u1ea7u v\u1ec1 ch\u1ea5t l\u01b0\u1ee3ng phi l\u00e2m s\u00e0ng\/l\u00e2m s\u00e0ng \u0111\u1ed1i v\u1edbi li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o (B\u1ea3n th\u1ea3o, 2019)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">N\u00ean tr\u00e1nh s\u1eed d\u1ee5ng thu\u1ed1c th\u1eed c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt, thay v\u00e0o \u0111\u00f3 s\u1eed d\u1ee5ng c\u00e1c thu\u1ed1c th\u1eed kh\u00f4ng ch\u1ee9a th\u00e0nh ph\u1ea7n \u0111\u1ed9ng v\u1eadt v\u00e0 c\u00f3 th\u00e0nh ph\u1ea7n x\u00e1c \u0111\u1ecbnh. \u0110i\u1ec1u n\u00e0y gi\u00fap gi\u1ea3m thi\u1ec3u c\u00e1c t\u00e1c nh\u00e2n b\u1ea5t ng\u1edd d\u1eabn \u0111\u1ebfn c\u00e1c y\u00eau c\u1ea7u th\u1eed nghi\u1ec7m b\u1ed5 sung.&nbsp;<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"EMA_%E2%80%93_Huong_dan_ve_cac_san_pham_thuoc_dua_tren_te_bao_nguoi_2008\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:16pt\"><strong>EMA \u2013 H\u01b0\u1edbng d\u1eabn v\u1ec1 c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c d\u1ef1a tr\u00ean t\u1ebf b\u00e0o ng\u01b0\u1eddi (2008)<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">Khuy\u1ebfn kh\u00edch s\u1eed d\u1ee5ng c\u00e1c ch\u1ea5t thay th\u1ebf t\u1ed5ng h\u1ee3p cho huy\u1ebft thanh b\u1ea5t c\u1ee9 khi n\u00e0o c\u00f3 th\u1ec3. N\u1ebfu s\u1eed d\u1ee5ng huy\u1ebft thanh b\u00f2, n\u00ean c\u00e2n nh\u1eafc huy\u1ebft thanh chi\u1ebfu x\u1ea1 \u03b3 ho\u1eb7c m\u00f4i tr\u01b0\u1eddng t\u1ed5ng h\u1ee3p.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Su_chuyen_doi_sang_moi_truong_nuoi_cay_CD_va_AOF\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>S\u1ef1 chuy\u1ec3n \u0111\u1ed5i sang m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y CD v\u00e0 AOF<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">\u0110\u1ea9y m\u1ea1nh v\u1ec1 m\u1eb7t quy \u0111\u1ecbnh kh\u00f4ng ch\u1ec9 l\u00e0 chuy\u1ec3n sang c\u00e1c gi\u1ea3i ph\u00e1p&nbsp;<strong>Xeno-Free<\/strong> m\u00e0 c\u00f2n \u1ee7ng h\u1ed9 c\u00e1c v\u1eadt li\u1ec7u \u201c\u0110\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh v\u1ec1 m\u1eb7t h\u00f3a h\u1ecdc\u201d (CD) v\u00e0 \u201cKh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt\u201d (AOF) \u0111\u1ec3 c\u00f3 quy tr\u00ecnh s\u1ea3n xu\u1ea5t an to\u00e0n v\u00e0 nh\u1ea5t qu\u00e1n h\u01a1n.&nbsp;<\/span><\/p>\n<ul>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\"><strong>M\u00f4i tr\u01b0\u1eddng CD<\/strong> (<i>Chemically Defined &#8211; \u0110\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh v\u1ec1 m\u1eb7t h\u00f3a h\u1ecdc<\/i>): Cung c\u1ea5p kh\u1ea3 n\u0103ng t\u00e1i t\u1ea1o t\u1ed1t h\u01a1n v\u00e0 tu\u00e2n th\u1ee7 quy \u0111\u1ecbnh b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng c\u00e1c th\u00e0nh ph\u1ea7n c\u00f3 th\u00e0nh ph\u1ea7n \u0111\u01b0\u1ee3c x\u00e1c \u0111\u1ecbnh \u0111\u1ea7y \u0111\u1ee7.&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\"><strong>M\u00f4i tr\u01b0\u1eddng AOF<\/strong> (<i>Animal Origin Free &#8211; Kh\u00f4ng c\u00f3 ngu\u1ed3n g\u1ed1c \u0111\u1ed9ng v\u1eadt)<\/i>: Lo\u1ea1i b\u1ecf r\u1ee7i ro c\u1ee7a c\u00e1c ch\u1ea5t g\u00e2y \u00f4 nhi\u1ec5m c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb \u0111\u1ed9ng v\u1eadt, n\u00e2ng cao t\u00ednh an to\u00e0n c\u1ee7a s\u1ea3n ph\u1ea9m.&nbsp;<\/span><\/li>\n<\/ul>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">\u0110\u1ec3 li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 gen \u0111\u00e1p \u1ee9ng c\u00e1c ti\u00eau chu\u1ea9n an to\u00e0n v\u00e0 ch\u1ea5t l\u01b0\u1ee3ng cao, th\u00ec vi\u1ec7c chuy\u1ec3n \u0111\u1ed5i sang v\u1eadt li\u1ec7u CD\/AOF kh\u00f4ng c\u00f2n l\u00e0 t\u00f9y ch\u1ecdn m\u00e0 l\u00e0 \u0111i\u1ec1u c\u1ea7n thi\u1ebft.&nbsp;<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Ban_da_san_sang_cho_su_chuyen_doi_trong_nuoi_cay_te_bao\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>B\u1ea1n \u0111\u00e3 s\u1eb5n s\u00e0ng cho s\u1ef1 chuy\u1ec3n \u0111\u1ed5i trong nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o?<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">Nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o trong m\u00f4i tr\u01b0\u1eddng CD\/AOF l\u00e0 l\u1ef1a ch\u1ecdn ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf m\u1edbi, nh\u1eb1m \u0111\u1ea3m b\u1ea3o t\u00ednh an to\u00e0n v\u00e0 tu\u00e2n th\u1ee7 trong nghi\u00ean c\u1ee9u v\u00e0 s\u1ea3n xu\u1ea5t. Tuy nhi\u00ean, \u0111\u00e2u l\u00e0 l\u1ef1a ch\u1ecdn hi\u1ec7u qu\u1ea3 cao gi\u1eefa h\u00e0ng lo\u1ea1t s\u1ea3n ph\u1ea9m m\u00f4i tr\u01b0\u1eddng CD\/AOF?<\/span><a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/www.xcell.co.kr\/\"><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:11pt\"> Xcell Therapeutics&nbsp;<\/span><\/a><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">l\u00e0 chuy\u00ean gia trong s\u1ea3n xu\u1ea5t m\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o v\u1edbi&nbsp;<\/span><a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/biogroupvietnam.com\/san-pham\/moi-truong-cellcor-cd-msc-aof\"><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:11pt\">CellCor\u2122 MSC CD AOF<\/span><\/a><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\"> \u0111\u00e1p \u1ee9ng \u0111\u1ea7y \u0111\u1ee7 c\u00e1c y\u00eau c\u1ea7u kh\u1eaft khe trong nghi\u00ean c\u1ee9u. M\u00f4i tr\u01b0\u1eddng nu\u00f4i c\u1ea5y CellCor\u2122 MSC CD AOF s\u1ebd gi\u00fap c\u00e1c nh\u00e0 nghi\u00ean c\u1ee9u v\u00e0 doanh nghi\u1ec7p c\u00f4ng ngh\u1ec7 sinh h\u1ecdc th\u00edch \u1ee9ng d\u1ec5 d\u00e0ng h\u01a1n v\u1edbi s\u1ef1 chuy\u1ec3n \u0111\u1ed5i n\u00e0y.<\/span><\/p>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\">Biogroup Vietnam lu\u00f4n s\u1eb5n s\u00e0ng h\u1ed7 tr\u1ee3 b\u1ea1n th\u00edch \u1ee9ng v\u1edbi nh\u1eefng quy \u0111\u1ecbnh ng\u00e0y c\u00e0ng kh\u1eaft khe c\u1ee7a qu\u1ed1c t\u1ebf. H\u00e3y li\u00ean l\u1ea1c v\u1edbi ch\u00fang t\u00f4i \u0111\u1ec3 nh\u1eadn t\u01b0 v\u1ea5n v\u1ec1 s\u1ea3n ph\u1ea9m v\u00e0 gi\u1ea3i ph\u00e1p chuy\u1ec3n \u0111\u1ed5i trong nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">\ud83d\udce9&nbsp;<\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:13.999999999999998pt\"><strong>Th\u00f4ng tin li\u00ean h\u1ec7:<\/strong><\/span><\/p>\n<ul>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Website:<\/strong><\/span><a target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/biogroupvietnam.com\/public\/lien-he\"><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\">&nbsp;<\/span><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">https:\/\/biogroupvietnam.com\/public\/lien-he<\/span><\/a><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Hotline:<\/strong> +84 963 621 421&nbsp;<\/span><\/li>\n<li><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:12pt\"><strong>Email:<\/strong>&nbsp;<\/span><span style=\"background-color:transparent;color:#1155cc;font-family:Arial,sans-serif;font-size:12pt\">info@biogroupvietnam.vn<\/span><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Phu_luc\"><\/span><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:20pt\"><strong>Ph\u1ee5 l\u1ee5c<\/strong><\/span><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<figure class=\"image\"><img decoding=\"async\" style=\"aspect-ratio:602\/403\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/09\/unnamed.png\" alt=\"Xu h\u01b0\u1edbng th\u1ecb tr\u01b0\u1eddng sau khi c\u00f3 quy \u0111\u1ecbnh m\u1edbi \u0111\u1ec3 ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o ho\u1eb7c di truy\u1ec1n (Ngu\u1ed3n: Xcell Therapeutics)\" width=\"602\" height=\"403\"><figcaption><span style=\"background-color:transparent;color:#000000;font-family:Arial,sans-serif;font-size:11pt\"><i>Xu h\u01b0\u1edbng th\u1ecb tr\u01b0\u1eddng sau khi c\u00f3 quy \u0111\u1ecbnh m\u1edbi \u0111\u1ec3 ph\u00e1t tri\u1ec3n li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o ho\u1eb7c di truy\u1ec1n (Ngu\u1ed3n: Xcell Therapeutics)<\/i><\/span><\/figcaption><\/figure>\n<p style=\"text-align:center\">&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Khi l\u0129nh v\u1ef1c li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 gen ti\u1ebfn tri\u1ec3n, c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u0111ang th\u1eaft ch\u1eb7t c\u00e1c h\u01b0\u1edbng d\u1eabn xung quanh vi\u1ec7c s\u1eed d\u1ee5ng Huy\u1ebft thanh b\u00e0o thai b\u00f2 (FBS) v\u00e0 D\u1ecbch ly gi\u1ea3i ti\u1ec3u c\u1ea7u ng\u01b0\u1eddi (HPL). C\u00e1c c\u01a1 quan nh\u01b0 FDA v\u00e0 EMA hi\u1ec7n \u0111ang nh\u1ea5n m\u1ea1nh vi\u1ec7c s\u1eed d\u1ee5ng<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/nhung-thay-doi-ve-quy-dinh-trong-viec-su-dung-fbs-va-hpl\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":6046,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-4278","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL theo ti\u00eau chu\u1ea9n qu\u1ed1c t\u1ebf<\/title>\n<meta name=\"description\" content=\"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh s\u1eed d\u1ee5ng FBS v\u00e0 HPL t\u1eeb FDA, EMA v\u00e0 ICH Q5A(R2). 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